Genomic Investigation of Cardiovascular Diseases

NCT00722748 | Active Not Recruiting

• 1 other identifier: HSC004714
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. Human subject donation allows for the creation of the proposed genebank.

Conditions

Coronary Artery Disease; Myocardial Infarction; Atrial Fibrillation; Aortic Stenosis; Mitral Regurgitation; Idiopathic Cardiomyopathy

Keywords

Genebank; Gene registry; Cardiac Arrythmia Disease

Outcome Measures

Primary Outcomes (1)

• 38 cc of blood obtained for DNA analysis. Medical information -diagnosis, disease history, medical treatments, response to treatments, laboratory tests, subject's age, ethnic background, and if available, related family history.

  At the time of informed consent

Study Arms (1)

Genebank

By creating a genebank from patient's blood donations we will ultimately be able to define genes for various cardiovascular conditions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from Scripps Health general diagnostic population, cardiology population, and outside referrals. Upon meeting the inclusion/exclusion criteria, each eligible patient will be given a consent form and the study will be discussed with them in a face-to-face discussion with the principal investigator, one of the co-investigators or one of the research coordinators. The patient (or legal representative) must sign the informed consent form prior to any study related procedures being performed.

You may qualify if:

• Candidates for this study must meet ALL of the following criteria:
• Age 18 years or older
• Be reliable, cooperative and willing to comply with all protocol-specified procedures and sub-study if consented.
• Able to understand and grant informed consent
• Have at least one of the following (a-g):
• Coronary Artery Disease (defined as):
• Coronary artery bypass surgery or
• Lesion \>70% on cardiac or CT angiogram or
• Percutaneous Coronary Intervention
• Myocardial infarction (defined as):
• Diagnosed by elevated troponin level or
• Diagnosed by ST segment elevations on EKG or
• Diagnosed by pathologic Q waves on EKG or
• Documented in the medical record or by self report
• Atrial Fibrillation (defined as):

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Previously enrolled in The Genebank at Scripps Clinic Registry
• Any active bleeding (i.e. GI bleed).
• Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
• Treatment with any investigational agents or devices within 30 days preceding enrollment in the study.
• Been administered or taken any CNS sedatives or depressants in the past 12 hours.
• Been administered or taken any CNS sedatives or depressants in the past 12 hours.
• Subject's qualifying diagnosis is Atrial fibrillation and they are known to have any one of the following:
• Prior myocardial infarction, coronary artery bypass surgery, or percutaneous coronary intervention
• EF \< 45% at time of diagnosis (excluding tachycardia induced cardiomyopathy diagnosed by a cardiologist)
• Elevated left atrial pressures (\> 20 mmHg)
• Dilated left atrium (\> 4.0 cm or \>2.0 cm/m2 body surface)
• Mitral valve disease with significant valve pathology
• Mitral regurgitation/insufficiency greater than trace to mild on echo as determined by reading physician
• Rheumatic mitral valve disease

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Health

La Jolla, California, 92037, United States

Location

Related Links

• The webpage for Scripps Translational Science Institute

Biospecimen

Retention: SAMPLES WITH DNA

Cardiac Catheterization Patients Blood will be collected from the patients that will undergo heart catheterization for establishing a gene bank registry. Informed consent will take place prior to cardiac catheterization. 38 cc of blood collected will be processed to create a repository of DNA, RNA, and lymphoblastoid cell-line immortalization on selected patient populations, plasma and serum. The DNA will be amplified in certain patient populations to preserve the quantity.

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Atrial Fibrillation; Aortic Valve Stenosis; Mitral Valve Insufficiency; Cardiomyopathies

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Eric J Topol, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Translational Science Institute

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: June 1, 2007
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

US (1)